Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT05800951
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of acute AMI confirmed by a medical professional, with changes in serum biomarkers or evidence of ischemic EKG changes (STEMI or NSTEMI).
2. Cardiogenic Shock present as defined by the presence of 2 OR MORE of the following criteria prior to PCI:
* Hypotension: systolic blood pressure ≤ 90mmHg at baseline (prior to PCI) or the use of inotropes or vasopressors to maintain SBP ≥ 90mmHg
* Evidence of end organ hypoperfusion: elevated serum lactate levels (venous or arterial), cool extremities, oliguria/anuria
* Hemodynamic criteria: Cardiac Index of \< 2.2 L/min/m2 or a cardiac power output (CPO) of ≤ 0.6 watts
3. Patient underwent PCI within 12 hours of hospital presentation.
Exclusion Registry Exclusion Criteria:
AMICS patients who meet any of the following study exclusion criteria will have a limited set of data collected via a single-page Patient Exclusion Form completed and submitted within 45 days of hospital discharge, which includes the reason for exclusion, date of index PCI, and assessment of patient survival to hospital discharge:
1. Evidence of Anoxic Brain Injury
2. Unwitnessed out of hospital cardiac arrest or any cardiac arrest in which return of spontaneous circulation (ROSC) is not achieved within 30 minutes
3. IABP placed prior to MCS
4. Septic, anaphylactic, hemorrhagic, and neurologic causes of shock
5. Non-ischemic causes of shock/hypotension (pulmonary embolism, pneumothorax, myocarditis, tamponade, etc.)
6. Active bleeding for which MCS is contraindicated
7. Recent major surgery for which MCS is contraindicated
8. Mechanical complications of AMI (acute ventricular septal defect (VSD) or acute papillary muscle rupture)
9. Known left ventricular thrombus for which MCS is contraindicated
10. Mechanical aortic prosthetic valve
11. Contraindication to intravenous systemic anticoagulation which precludes placement of MCS.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05800951
Study Brief:
Protocol Section:
NCT05800951